Newsletters

For over 35 years, Devices & Diagnostics Letter has been a must-read for leaders in the device and diagnostics industries who need to stay in compliance and avoid costly design and production mistakes. Each weekly issue provides the latest regulatory news, including Part 11 compliance, software validation rules and other pre- and post-market requirements, and tells you how to slash research time, speed your products through the approval process, pass facility inspections, and more. In every issue, you get links to key documents, such as draft and final guidances, warning letters, proposed and final rules, closeout letters, full texts of proposed legislation, GAO reports, and many others.

The International Medical Device Regulatory Monitor helps devicemakers stay on top of recent regulatory actions around the world – in emerging markets like the EU, Brazil, Russia, China, Turkey and others – ensuring that your launches are successful and your growth continues in the right markets. With it, you'll save hundreds of hours of research time and thousands of dollars, plus stay far ahead of your competition. In every issue, you also get complete official English-language texts of key, hard-to-obtain proposals, regulations, directives, guidances and other regulatory documents.

For 30 years, medical device manufacturers worldwide have relied on The GMP Letter to comply with FDA's interpretation and enforcement of cGMPs and the Quality System Regulation (QSR). In each issue, you get an update on regulations and guidances and learn which companies the FDA has inspected and what they've found. You also get links to 483s, warning letters, closeout letters, FDA policy notices, and many other reports to help make your quality assurance efforts a success.